肾移植患者低FK-506血药浓度与早期急性排斥的关系研究

The Analysis of Low Tacrolimus Concentrations and Increased Risk of Early Acute Rejection in Renal Transplantation

目的 探讨肾移植患者低FK506血药浓度与早期急性排斥发生的关系。方法 本文通过ELISA方法检查来自30例肾移植患者349份血标本。根据血清肌酐的升高来判断器官排斥的发生，12例被考虑有排斥，其中5个病人通过活检确证，移植术后一个月或到第一次排斥的排斥患者与非排斥患者进行FK506血药浓度分析。结果活检诊断的排斥患者比非排斥患者的FK506血药浓度要低（P=0．03），所有排斥患者比非排斥患者的FK506血药浓度同样要低（P=0．04）。活检诊断的排斥患者平均血药浓度为5．09±1．16ng／mL（x±s），而非排斥患者为9．20±3．52ng／mL；排斥患者平均FK506血药浓度为5．57±1．47ng／mL，而非排斥患者为9．20±3．52ng／mL。55％排斥患者血药浓度为0～10ng／mL，血药浓度为10～15ng／mL时没有观察到排斥患者。结论 肾移植术后第一个月内血药浓度与肾移植早期急性排斥有显著性相关。低FK506血药浓度患者更易于发生排斥。肾移植术后第一个月内FK506血药浓度应大于10ng／mL。

Objective An analysis was performed on renal transplant recipients to evaluate the relationship between tacrolimus trough concentrations and the development of rejection after transplant. Methods A total of 349 concentrations from 30 patients, measured by enzyme- linked immunosorbent assay （ELISA）, were recorded. Based on an increased serum creatine, 12 patients were considered to have organ rejection. Rejection was confirmed by biopsy in five of these. The median trough concentration of tacrolimus over the first month of therapy, or until the time of first rejection was compared in rejecters vs non - rejectors. Results Median trough concentrations of ta- crolimus were found to be lower in biopsy - proven rejecters vs non - rejectors （ P = 0.03 ） and all rejectors vs non - rejectors （P = 0.04） .The average median concentration（x ± s） in the biopsy- proven rejecter group was 5.09 ±1.16 ng/mL, compared to 9.20 ± 3.52 ng/mL in the non - rejecter group . The average median concentration in all rejecters was 5.57± 1.47 ng/mL, compared with 9.20 ± 3.52 ng/mL in non- rejectors. A rejection rate of 55 % was found for patients with a median trough concentration between 0 and 10 ng/mL. No rejection in patients was observed with a median trough concentration between 10 and 15 ng/mL. Conduson A significant relationship exists between organ rejection and median tacmlimus trough concentrations in the first month post- transplant; patients with low concentrations were more likely to reject. Trough concentration greater than 10 ng/mL must be achieved in the first month after renal transplantation.